Recruiting

Dopaminergic Progenitor Cells for Parkinson's Disease Treatment

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What is being tested

Allogeneic dopaminergic neural precursor cell(NCR201)

Drug
Who is being recruted

Synucleinopathies+6

+ Basal Ganglia Diseases

+ Brain Diseases

From 40 to 75 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: June 2025
See protocol details

Summary

Principal SponsorNuwacell Biotechnologies Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 6, 2025

Actual date on which the first participant was enrolled.

This study is exploring a new treatment for Parkinson's disease, a condition that affects many middle-aged and elderly individuals, leading to symptoms like tremors, difficulty moving, and muscle stiffness. As the number of people affected by Parkinson's continues to rise, finding effective treatments becomes crucial. The study investigates the use of a special type of cell, called human induced pluripotent stem cell-derived dopaminergic progenitor cells, to see if they can safely help improve symptoms for those with Parkinson's disease. Participants in this study receive an injection of these specialized cells. The main focus is to evaluate whether this treatment is safe and can be tolerated by patients. The study also looks at how effective the treatment is in easing Parkinson's symptoms. As this is a Phase I trial, the goal is primarily to gather information on safety and tolerability, which is essential before considering larger studies. Participants are monitored closely to assess how their symptoms change and to ensure any risks are managed.

Official TitleA Phase I, Open Label, Single Arm, Dose Escalation and Dose Expansion Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Human Induced Pluripotent Stem Cell Derived Dopaminergic Progenitor Cells (NCR201) Injection in the Treatment of Subjects With Parkinson's Disease
NCT06978920
Principal SponsorNuwacell Biotechnologies Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

SynucleinopathiesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersNervous System DiseasesParkinson DiseaseNeurodegenerative DiseasesParkinsonian Disorders

Criteria

5 inclusion criteria required to participate
Ages between 40 and 75 years;
Diagnosed to be Parkinson's disease according to Parkinson's disease diagnostic criteria;
Disease history over 5 years;
Stable dose of dopamine treatment;
Show More Criteria
6 exclusion criteria prevent from participating
Patients who have previously undergone brain surgery;
Past use of stem cell therapy or participation in stem cell clinical research;
Cognitive impairment;
History of mental disorders;
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
MRI-guided bilateral stereotactic cell implantation

Group II

Experimental
MRI-guided bilateral stereotactic cell implantation

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

The First Affiliated Hospital of USTC

Hefei, ChinaOpen The First Affiliated Hospital of USTC in Google Maps
Recruiting
One Study Center